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Quality Engineer
Medical Device/Product Development /Remediation Project
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Location: State of, MA
Pay Rate: Contract: 80 to 90.00 $/hr
Salary: 166.40 to 187.20 K$/yr
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Position Type/ Job Duration: Temp-to-hire
Education Required: BS Engineering/Technical 
Years Experience Required: 0

Industry:
Medical
Job Posted: 12/5/2017
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Apply Deadline: 12/20/2017
Job #: 136074DWG
Job order status: Client is actively seeking candidates
Relocation available: Not Available


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Medical Device company needs a Sr Design Quality Engineer in Mansfield MA to support product development activities for a remediation project. This is a year long contract, likely extension up to 30 months. Must have the proven ability to directly lead and/or co-lead multiple tasks and projects. Great contractor benefits

Responsibilities

  • Support the development and manufacturing of medical devices in conformance with the Quality System Regulation, ISO 13485, Medical Device Directive, ISO 14971, IEC 60601 and other regulatory standards
  • Ensure internal Design Control policies and procedures comply with regulations and external standards, including software regulations, risk management, and change control
  • Contribute to the streamlining and continuous improvement of the product development process to ensure robust and efficient development and launch of new and innovative healthcare products
  • Provide guidance for the application of internal development procedures, including Design Control, to the product development teams, within the framework of regulatory requirements
  • Interact and form constructive working relationships with all levels of leadership within Quality, Procurement, Marketing, R&D, and Operations

Requirements

  • BS in Engineering
  • Minimum 5 years medical devices experience in a Quality or R&D Engineering position focused on product development for remediation efforts
  • Strong understanding of industry expectations in the areas such as voice of customer, specification development, risk management, design verification and validation, stability studies, sterilization validation, biocompatibility, transportation testing, etc.
  • Working knowledge of quality engineering principles, supplier management, and manufacturing operations within a regulated industry
  • Working knowledge of electro-mechanical devices, software validation methods, and/or plastics related manufacturing
  • Certified Quality Engineer (CQE) preferred
  • DFSS or DMAIC Black Belt Certified preferred
  • Certified Quality Auditor (CQA) preferred

Benefits

  • Insurance, 401K,PTO
 
 
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Related Keywords medical device,quality,product quality,quality audit,process quality,manufacturing quality. regulatory compliance, product development, remediation
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